Gufic Bioscience Told To Submit More Data for Piperacillin-Tazobactam-Sodium Chloride FDC

This came after the firm presented their proposal along with justification for BE & Phase III CT waiver before the committee.

Piperacillin is a broad-spectrum antibiotic used to treat various bacterial infections, often combined with tazobactam to enhance its effectiveness against bacteria that produce beta-lactamase enzymes.

Tazobactam is a beta-lactamase inhibitor used in combination with the antibiotic piperacillin to treat bacterial infections. It works by preventing bacteria from destroying piperacillin, allowing the antibiotic to effectively kill the bacteria.

Sodium chloride, also known as salt, common salt, table salt or halite, is an ionic compound with the chemical formula NaCl, representing a 1:1 ratio of sodium and chloride ions. Sodium chloride is the primary salt in seawater and in the extracellular fluid of many multicellular organisms

At the recent SEC meeting for Antimicrobial and Antiviral held on 14th May 2025, the expert panel reviewed the proposal along with justification for BE & Phase III CT waiver before the committee.

After detailed deliberation, the committee opined the following:

1. The strength of diluent i.e. Sodium chloride injection 0.9%w/v is different from similar USFDA approved product.

2. The firm should present more scientific literature available from peer reviewed journal in support of the proposed FDC with Sodium chloride injection 0.9%w/v.

Accordingly, the firm should submit the above justification for further review by the committee.

Also Read: Intas Gets CDSCO Panel Nod to Conduct Phase III Trial of Pertuzumab Biosimilar for Breast Cancer